Tonix Pharmaceuticals Holding Corp.·Healthcare

TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years

TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS)1,2 was presented by Mark S.

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) shares are trading lower Monday morning, hitting a fresh 52-week low as investors weigh a new SEC filing alongside a biotech pipeline update from late last week.

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia

Monday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease

BERKELEY HEIGHTS, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that Seth Lederman, MD, Chief Executive Officer, will deliver a company presentation at BIO-Europe Spring 2026, being held March 23-25, 2026, in Lisbon, Portugal.
Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, focuses on discovering, acquiring, developing, and licensing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Its portfolio includes immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. The company's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer, including TNX-1500, a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. Its rare disease portfolio comprises TNX-2900 for the treatment of Prader-Willi syndrome. The company's infectious disease pipeline includes TNX-801, a vaccine to prevent smallpox and monkeypox; TNX-1840 and TNX-1850 that are live virus vaccines based on its recombinant pox vaccine (RPV) platform for COVID-19; TNX-3500, a small molecule antiviral drug to treat acute COVID-19; and TNX-102 SL, a small molecule drug to treat Long COVID, a chronic post-acute COVID-19 condition. Its CNS portfolio includes small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions, including TNX-102 SL, which is in mid-Phase 3 development for the management of fibromyalgia; TNX-1900 that is in development for the prevention of migraine headache; and TNX-1300, a biologic designed to treat cocaine intoxication. The company was founded in 2007 and is headquartered in Chatham, New Jersey.
Healthcare
Biotechnology
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2012-05-10
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